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Feasibility Study of 68Ga-PSMA PET-CT and 18F-FDOPA PET-CT in Glioblastoma's Patients (PAraDiGM)

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ClinicalTrials.gov Identifier: NCT03903419
Recruitment Status : Recruiting
First Posted : April 4, 2019
Last Update Posted : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Leon Berard

Tracking Information
First Submitted Date  ICMJE March 28, 2019
First Posted Date  ICMJE April 4, 2019
Last Update Posted Date August 7, 2019
Actual Study Start Date  ICMJE January 16, 2019
Estimated Primary Completion Date January 16, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 3, 2019)
  • Comparison of Maximum Standardized Uptake Values of 68Ga-PSMA and of 18F-FDOPA PET-CT in glioblastomas recurrences and radiation-related complications after radiotherapy. [ Time Frame: 1 week ]
    Maximum Standardized Uptake Values (SUVmax) of both 68Ga-PSMA and 18F-FDOPA.
  • Comparison of Target to Background Ratio of 68Ga-PSMA and of 18F-FDOPA PET-CT in glioblastomas recurrences and radiation-related complications after radiotherapy. [ Time Frame: 1 week ]
    Target to Background Ratio (TBR) of both 68Ga-PSMA and 18F-DOPA.
  • Comparison of Target to Background Ratio and Target to Striatum Ratio of 68Ga-PSMA and of 18F-FDOPA PET-CT in glioblastomas recurrences and radiation-related complications after radiotherapy. [ Time Frame: 1 week ]
    Target to Background Ratio (TBR) of 68Ga-PSMA and Target to Striatum Ratio of 18F-DOPA.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03903419 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 5, 2019)
  • Ability of 68Ga-PSMA PET-CT to distinguish radiation-related complications from recurrent tumor using MRI and clinical evaluation as gold standards. [ Time Frame: 3 months ]
    Performances calculated basing on morphological parameters (uptake of tracer).
  • Ability of 18F-FDOPA PET-CT to distinguish radiation-related complications from recurrent tumor using MRI and clinical evaluation as gold standards. [ Time Frame: 3 months ]
    Performances calculated basing on morphological parameters (uptake of tracer).
  • Concordance between 68Ga-PSMA and 18F-FDOPA PET-CT from visual interpretation. [ Time Frame: 1 week ]
    Measure of agreement between the two techniques using Kappa coefficient (visual).
  • PSMA expression on initial glioblastoma sample by immunohistochemistry (IHC). [ Time Frame: 3 months ]
    PSMA expression by immunohistochemistry (IHC).
  • Correlation between PSMA expression (IHC) and 68Ga- PSMA PET-CT imaging data. [ Time Frame: 3 months ]
    Correlation between IHC and SUVmax and TBR.
  • Assessment of safety will be based mainly on the frequency of adverse events according to the common toxicity criteria (CTCAE v5.0) grade [ Time Frame: 3 months ]
    The assessment of safety will be based mainly on the frequency of adverse events according to the common toxicity criteria (CTCAE v5.0) grade.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2019)
  • Ability of 68Ga-PSMA PET-CT to distinguish radiation-related complications from recurrent tumor using MRI and clinical evaluation as gold standards. [ Time Frame: 3 months ]
    Performances calculated basing on morphological parameters (uptake of tracer).
  • Ability of 18F-FDOPA PET-CT to distinguish radiation-related complications from recurrent tumor using MRI and clinical evaluation as gold standards. [ Time Frame: 3 months ]
    Performances calculated basing on morphological parameters (uptake of tracer).
  • Concordance between 68Ga-PSMA and 18F-FDOPA PET-CT from visual interpretation. [ Time Frame: 1 week ]
    Measure of agreement between the two techniques using Kappa coefficient (visual).
  • PSMA expression on initial glioblastoma sample by immunohistochemistry (IHC). [ Time Frame: 3 months ]
    PSMA expression by immunohistochemistry (IHC).
  • Correlation between PSMA expression (IHC) and 68Ga- PSMA PET-CT imaging data. [ Time Frame: 3 months ]
    Correlation between IHC and SUVmax and TBR.
  • Tolerance. [ Time Frame: 3 months ]
    Toxicities assessed according to NCI CTACAE v5.0.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Feasibility Study of 68Ga-PSMA PET-CT and 18F-FDOPA PET-CT in Glioblastoma's Patients
Official Title  ICMJE Feasibility Study for the Realization of 68Ga-PSMA PET-CT and 18F-FDOPA PET-CT for Identification of Early Recurrence in Patients Treated With Radiotherapy for Glioblastoma
Brief Summary

This study is a non-randomized, prospective, monocentric feasibility study assessing 68Ga-PSMA PET-CT and 18F-FDOPA PET-CT to differentiate early recurrence from post-radiation modifications in patients treated with radiotherapy for glioblastoma.

Patients with clinical symptoms of relapse within 3 to 9 months of follow-up3 months after the end of radiotherapy, and/or with doubtful MRI between radiation-related complications and recurrence, will be referred for both 68Ga-PSMA and 18F-FDOPA PET-CT.

The rationale of doing 68Ga-PSMA and 18F-FDOPA brain PET-CT in each case will be discussed in detail with the referring physician and an informed consent will be taken from each patient for the study. The two imaging studies will be done at least with a gap of 6 hours, using the same PET-CT scanner.

Detailed Description

Gliomas are the most common primary intra-axial brain tumors arising from the glial cells. The reference treatment consists in a surgical removal followed by radiotherapy and chemotherapy (Temozolomide).

Because of frequent recurrences after first-line therapy, an accurate neuroimaging is needed. The reference anatomical modality is represented by Magnetic Resonance Imaging (MRI), especially multimodal MRI (MRI with gadolinium injection associated with spectroscopy, perfusion and diffusion). One of the particular goals of this imaging is to discriminate recurrences after therapy from radiation-related complications, which can be challenging. These last ones are side effects which turn out after radiotherapy, particularly when high doses are delivered or if chemotherapy is associated. It can occur during the first 3 months after radiotherapy as a subacute radiation related side effects and is then denominated "pseudo-progression", or after the first 3 months of completing radiotherapy as a later and chronic inflammation radiation-related complication named radiation necrosis. It can display clinical symptoms and imaging features which can mimic a relapse. Biopsy is the gold standard but may be not feasible or inconclusive due to limited and non-representative sampling.

The functional nuclear imaging usually completes the anatomical imaging in the oncological response assessment, by providing further metabolic information. Many Positron Emission Tomography (PET) tracers have been studied such as 18F-FDG exploring glucose metabolism, 18F-FLT as a nucleoside analogue, and 18F-FDOPA, 18F-FET, 11C-MET which are radiolabeled amino acids.

A new promising PET radio-tracer is currently soaring. This is the Prostate Specific Membrane Antigen (PSMA) radiolabeled with Gallium 68, a positron emitter, readily available because of a "homemade synthesis". The PSMA is a transmembrane glycoprotein over-expressed in prostate adenocarcinomas

A few studies performed glioblastomas functional imaging based on this PSMA over expression. All achieved to display glioblastomas with 68Ga-PSMA PET-scanner. A recent publication performed on five patients compared 68Ga-PSMA and 18F-FDG in the diagnostic value of glioblastomas recurrence detection. 68Ga-PSMA showed better identification of recurrent lesions owing to a higher target to background ratio. However the place of this new promising tracer in the glioblastomas monitoring remains poorly documented.

Moreover, a study reported that 18F-FDOPA was more accurate than 18F-FDG in the diagnosis of brain tumor recurrence.

To the best of our knowledge, there are no findings concerning 68GA-PSMA and 18F-FDOPA comparison in distinguishing glioblastomas recurrence from radiation-related complications.

Because of the cost and availability of 68Ga-PSMA, if its performances were better than or similar to 18F-FDOPA ones, it could tend to replace this last one in the future. Whether it could be a surrogate to the 18F-FDOPA has not been elucidated yet, representing an interesting challenge.

In this study, the investigators will evaluate the feasibility of using 68Ga-PSMA PET-CT to distinguish recurrent glioblastomas from radiation-related complications, and its comparison with 18F-FDOPA. This study will not allow a proper evaluation of the sensitivity and specificity, which will be performed in a next larger research after completion of this preliminary phase.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Glioblastomas
Intervention  ICMJE Diagnostic Test: Feasibility study for the realization of 68Ga-PSMA PET-CT and 18F-FDOPA PET-CT for identification of early recurrence in patients treated with radiotherapy for glioblastoma.

This study is a non-randomized, prospective, feasibility study assessing 68Ga-PSMA PET-CT and 18F-FDOPA PET-CT to differentiate early recurrence from post-radiation modifications in patients treated with radiotherapy for glioblastoma.

Patients with clinical symptoms of relapse within 3 to 9 months of follow-up after the end of radiotherapy, and/or with doubtful MRI between radiation-related complications and recurrence, will be referred for both 68Ga-PSMA and 18F-FDOPA PET-CT.

Study Arms  ICMJE Experimental: 68Ga-PSMA PET-CT and 18F-FDOPA PET-CT
Functional imaging: 68Ga-PSMA and 18F-FDOPA PET-CT Immunohistochemistry of initial chirurgical sample with determination of PSMA expression
Intervention: Diagnostic Test: Feasibility study for the realization of 68Ga-PSMA PET-CT and 18F-FDOPA PET-CT for identification of early recurrence in patients treated with radiotherapy for glioblastoma.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 3, 2019)
16
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 16, 2021
Estimated Primary Completion Date January 16, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age ≥ 18 years.
  • Histologically proven glioblastoma.
  • Prior treatment with radiation therapy, with or without any concomitant treatment (e.g., chemotherapy).
  • Equivocal clinical and/or multimodal MRI evaluation within 3 to 9 months of follow-up after the end of radiotherapy with a doubt between tumor recurrence or radiation-related complications.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-3.
  • Covered by a medical insurance.
  • Signed informed consent.

Exclusion Criteria:

  • Pregnancy.
  • Breastfeeding.
  • Adults who are subject to a protective measure or who are unable to express their consent
  • Patients treated by Avastin within 3 months.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Aurélie MOREAU, M.D +33478782682 aurelie.moreau@lyon.unicancer.fr
Contact: David KRYZA, Pharm.D +33469856006 david.kryza@univ-lyon1.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03903419
Other Study ID Numbers  ICMJE ET18-143
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Centre Leon Berard
Study Sponsor  ICMJE Centre Leon Berard
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Aurélie MOREAU, M.D Centre Leon Berard
PRS Account Centre Leon Berard
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP